← Back to catalogue

Integra®

FDA UDI

Class I (US FDA UDI)

by Integra LifeSciences Production Corporation

Identity

Trade Name
Integra® FDA UDI
Generic Name
Middle ear file/rasp FDA UDI
Device Name
Integra® McGee Oval Window Rasp, Small, 0.4mm Diameter FDA UDI
Model / Reference
3722092 FDA UDI
Description
Integra® McGee Oval Window Rasp, Small, 0.4mm Diameter FDA UDI

Identifiers

Catalog Number
3722092 FDA UDI
Primary DI / UDI-DI
10381780082118 FDA UDI
FDA Product Code
JYY FDA UDI
GMDN Term
Middle ear file/rasp FDA UDI

Classification

Device Class
Class I FDA UDI
Regulation Number
874.4420 FDA UDI
Commercial Distribution
In Commercial Distribution FDA UDI

Clinical & Handling

Sterile

No

FDA UDI

Single Use

No

FDA UDI

Implantable

No

FDA UDI

Contains Latex

No

FDA UDI

Prescription Use

Yes

FDA UDI

Over-the-Counter

No

FDA UDI

Convenience Kit

No

FDA UDI

Combination Product

No

FDA UDI

HCT/P

No

FDA UDI

Premarket Exempt

Yes

FDA UDI

Lot / Batch Number

Yes

FDA UDI

Serial Number

No

FDA UDI

Expiration Date

No

FDA UDI

Manufacturing Date

Yes

FDA UDI
Sterilization Method
Moist Heat or Steam Sterilization FDA UDI

Dimensions & Sizes

Size
Angle — 15 degree FDA UDI
Outer Diameter — 0.4 Millimeter FDA UDI

Category: Middle ear file/rasp

Integra® by Integra LifeSciences Production Corporation — Class I — FDA UDI — listed in FDA GUDID — regulatory data on deviCERTS

Similar devices

Also classified as Middle ear file/rasp.

Authorization Coverage (1 country)

Regulatory Authorizations

United States Pending data

FDA UDI

Is this your device? Claim it to add documentation and request validation.

Manufacturer

Manufacturer
Integra LifeSciences Production Corporation

Sources (1)

  • FDA UDI 5bdd4b02-f156-4dd2-a8c3-cf825624858f 36 fields · synced Jun 9, 2026